Sabril (Oral Solution)

Warning

This medicine may cause eyesight problems like loss of eyesight. People taking Sabril (vigabatrin oral solution) do not lose all of their eyesight but loss of
eyesight can be very bad. Eyesight problems include not being able to see to the side when looking straight ahead and only being able to see
straight ahead. Blurred eyesight may also happen. If these eyesight problems happen, they will not get better. Eyesight problems may happen
within weeks of starting Sabril (vigabatrin oral solution) or sooner, or at any time while taking it, even after months or years. Talk with the doctor.

Call your doctor right away if you do not see things as well as before taking Sabril (vigabatrin oral solution). Call your doctor right away if you start to
trip, bump into things, or are more clumsy than normal. Call your doctor right away if people surprise you or if things that come in front of
you seem to come out of nowhere.

You will need to have your eyesight checked before starting Sabril (vigabatrin oral solution), while taking it, and for some time after you stop taking it. Talk
with your doctor.

If you have eyesight problems like loss of eyesight, are at risk for loss of eyesight, or are taking drugs that may cause eye problems,
talk with your doctor.

You may only get Sabril (vigabatrin oral solution) through a special program. Talk with your doctor.

Uses of Sabril:

What do I need to tell my doctor BEFORE I take Sabril?

If you have an allergy to vigabatrin or any other part of Sabril (vigabatrin oral solution).

If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what
signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.

If you are breast-feeding or plan to breast-feed.

This medicine may interact with other drugs or health problems.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check
to make sure that it is safe for you to take Sabril (vigabatrin oral solution) with all of your drugs and health problems. Do not start, stop, or change the dose of
any drug without checking with your doctor.

What are some things I need to know or do while I take Sabril?

For all patients taking Sabril (vigabatrin oral solution):

Tell all of your health care providers that you take Sabril (vigabatrin oral solution). This includes your doctors, nurses, pharmacists, and dentists.

Avoid driving and doing other tasks or actions that call for you to be alert or have clear eyesight until you see how Sabril (vigabatrin oral solution) affects
you.

Do not stop taking Sabril (vigabatrin oral solution) all of a sudden without calling your doctor. You may have a greater risk of seizures. If you need to stop this
drug, you will want to slowly stop it as ordered by your doctor.

This medicine may affect certain lab tests. Tell all of your health care providers and lab workers that you take Sabril (vigabatrin oral solution).

Nerve problems like burning, numbness, or tingling feelings that are not normal have happened with Sabril (vigabatrin oral solution). It is not known if these
nerve problems will go away if Sabril (vigabatrin oral solution) is stopped. Talk with the doctor.

Talk with your doctor before you drink alcohol or use other drugs and natural products that slow your actions.

If you are 65 or older, use Sabril (vigabatrin oral solution) with care. You could have more side effects.

Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using Sabril (vigabatrin oral solution)
while you are pregnant.

Children:

If your child's weight changes, talk with the doctor. The dose of Sabril (vigabatrin oral solution) may need to be changed.

This medicine may cause MRI changes that are not normal in infants. This has not been seen in older children or adults. It is not known if
these changes are harmful. Talk with the doctor.

How is this medicine (Sabril) best taken?

Use Sabril (vigabatrin oral solution) as ordered by your doctor. Read all information given to you. Follow all instructions closely.

Take with or without food.

Ask your doctor what to do if you are not able to take the full dose. Ask your doctor what to do if you throw up after taking Sabril (vigabatrin oral solution).

To gain the most benefit, do not miss doses.

Keep taking Sabril (vigabatrin oral solution) as you have been told by your doctor or other health care provider, even if you feel well.

Mix with water as told before you take Sabril (vigabatrin oral solution). Do not swallow the dry powder.

Follow how to use as you have been told by the doctor or read the package insert.

Be sure you know how many packets to use.

Melt each packet in 2 teaspoons (10 mL) of water.

After mixing, measure the liquid dose carefully. Use the measuring device that comes with Sabril (vigabatrin oral solution).

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your
doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing;
tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue,
or throat.

If seizures are worse or not the same after starting Sabril (vigabatrin oral solution).

Not able to control eye movements.

Very bad muscle pain or weakness.

Swelling.

Pain when passing urine.

Passing urine more often.

A big weight gain.

Memory problems or loss.

Trouble walking.

Patients who take Sabril (vigabatrin oral solution) may be at a greater risk of having thoughts or actions of suicide. The risk may be greater in people who have
had these thoughts or actions in the past. Call the doctor right away if signs like low mood (depression), nervousness, restlessness,
grouchiness, panic attacks, or changes in mood or actions are new or worse. Call the doctor right away if any thoughts or actions of suicide
occur.

What are some other side effects of Sabril?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical
help if any of these side effects or any other side effects bother you or do not go away:

If OVERDOSE is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was
taken, how much, and when it happened.

How do I store and/or throw out Sabril?

Store in the original container at room temperature.

Store in a dry place. Do not store in a bathroom.

Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.

Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your
pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Consumer information use

If your symptoms or health problems do not get better or if they become worse, call your doctor.

Do not share your drugs with others and do not take anyone else's drugs.

Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.

Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.

This medicine comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time Sabril (vigabatrin oral solution) is
refilled. If you have any questions about Sabril (vigabatrin oral solution), please talk with the doctor, pharmacist, or other health care provider.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was
taken, how much, and when it happened.